Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc.

- Prostate Biopsy Testing System

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IsoPSA Proceed to biopsy only when needed. IsoPSA is now included in NCCN® Prostate Cancer Early Detection Guidelines. IsoPSA can help reduce unnecessary prostate biopsies by up to 55%. Up to 75% of results from prostate biopsies performed in the US are negative for high-grade disease. By singling out PSA proteins that came from cancer cells, the IsoPSA test can help identify men who would not benefit from a biopsy.

What is the IsoPSA Test?

A simpler, more accurate way to assess risk of having high-grade cancer
Prostate cancer can cause PSA levels to increase, but so can benign factors such as enlargement of the prostate, infections, sexual activity–even undergoing a prostate exam. IsoPSA is an additional test for men that helps determine whether cancer may be the cause of their elevated PSA levels.

How is IsoPSA better?

Clearer results to help rule out unnecessary biopsies
Unlike the PSA test, which measures the total amount of PSA protein circulating in the blood, IsoPSA can help identify certain types of PSA proteins that were made by cancer cells. This insight provides greater clarity for ruling out risk of high-grade, aggressive cancer and the need for a prostate biopsy.

Who is IsoPSA for?

For men over 50 with elevated PSA levels
IsoPSA is indicated for men over 50 who have elevated PSA levels (>4ng/mL).

Alpha blockers and 5α-reductase inhibitors commonly prescribed for benign prostate hyperplasia (BPH) don’t interfere with IsoPSA results.

IsoPSA Experience

Ordering an IsoPSA test is easy. A blood sample is collected just like a PSA test, the specimen is sent to the laboratory, and the results are available 3-5 days later.

Single cut-off, not a risk range

Single cut-off, not a risk range
IsoPSA results are reported as a single cut-off providing clear, easy-to-interpret results

  • IsoPSA Index: 4.5
  • Risk Threshold: >6.0

Ideal for patient counsel: Easy to read and understand, IsoPSA results give physicians clear information to present to their patients to improve shared decision-making.

Our Science

SIA technology determines a protein’s origin based on its structure to determine if a patient has cancer

Solvent interaction analysis (SIA) uniquely focuses on detecting types of protein biomarkers that are directly related to disease

Our proprietary Solvent Interaction Analysis-based technology is tunable to detect underlying cancer biology by measuring changes in the structure of proteins. Adding information on the origin of a biomarker to the current measurement of concentration can add accuracy, specificity, and clarity to cancer diagnostics.

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